Notice of Change to Funds Available and Award Budget for PAR-13-232 "Advancing Medical Device Postmarket Surveillance Infrastructure and Epidemiologic Methodologies through Multi-stakeholder Partnership (U01)"

Notice Number: NOT-FD-15-005

Key Dates
Release Date: April 13, 2015

Related Announcements
PAR-13-232

Issued by
U.S. Food and Drug Administration (FDA)

Purpose

The purpose of this Notice is to change the Funds Available and Award Budget for PAR-13-232.

Now Reads:


Funds Available and Anticipated Number of Awards

FDA/CDRH intends to commit up to an estimated amount of $1,100,000 in FY 2013. The number of awards is contingent upon FDA appropriations, and the submission of a sufficient number of meritorious applications.

Future year amounts will be contingent on availability of Federal funds but it is estimated that FDA/CDRH will commit up to the following amounts for FY14-17:

FY2014: $1,100,000

FY2015: $1,100,000

FY2016: $1,100,000

FY2017: $1,100,000

Award Budget

Application budgets need to reflect the actual needs of the proposed project and should not exceed the following in total costs.

Year 01: $1,100,000

Year 02: $1,100,000

Year 03: $1,100,000

Year 04: $1,100,000

Year 05: $1,100,000

Funding will be provided for one year, with the possibility of up to four years of additional support. Future year amounts will be contingent on performance and continued availability of federal funds.

 

Should Read:


Funds Available and Anticipated Number of Awards

The anticipated number of awards is contingent upon FDA appropriations and the submission of a sufficient number of meritorious applications. Future year amounts will depend on annual appropriations, availability of funding and awardee performance.

It is anticipated that any award(s) made will not exceed $3,000,000 in total costs (direct plus indirect), per year, per award.

Award Budget

Application budgets need to reflect the actual needs of the proposed project and should not exceed the following in total costs (direct plus indirect).

Year 01: $3,000,000

Year 02: $3,000,000

Year 03: $3,000,000

Year 04: $3,000,000

Year 05: $3,000,000

Funding will be provided for one year, with the possibility of up to four years of additional support. Future year amounts will depend on annual appropriations, availability of funding and awardee performance.

Inquiries

Please direct all inquiries to:

Lisa Ko
U.S. Food and Drug Administration (FDA)
Telephone: 240-402-7592
Email: Lisa.Ko@fda.hhs.gov